Part-Time QA Consultant

Piper Companies is seeking a QA Consultant to join a Biotechnology company located in Philadelphia, PA through a part-time, hybrid (but primarily remote) contract. The QA Consultant will require an average of 20 hours of work per week. This role is critical to ensuring the development and execution of a Quality Management System (QMS) that not only meets but surpasses FDA and GMP regulatory standards as we advance our innovative technology toward commercialization.

Responsibilities of the QA Consultant include:

* QMS Development & Oversight:
Develop, implement, and sustain Quality Management System (QMS) procedures and SOPs specifically designed for cell-derived nanoparticle (CDNP) manufacturing.

* Regulatory Compliance:
Ensure all processes, materials, and documentation adhere to FDA Advanced Manufacturing Technology (AMT) regulatory requirements.

* Audit Leadership:
Lead internal quality audits and coordinate team readiness for external regulatory inspections.

* Document Governance:
Review and approve GMP documentation, including batch records, deviation reports, CAPAs, and change control documentation.

* Risk Assessment & Mitigation:
Conduct risk assessments across manufacturing operations and the supply chain to proactively identify and mitigate quality risks.

* Quality Advisory Support:
Provide strategic quality and quality-by-design (QbD) guidance to Technical Operations and R&D teams.

Qualifications for the QA Consultant include:

* Education:

Bachelor's or Master's degree in Biology, Biotechnology, Chemistry, or a closely related scientific discipline.

* Experience:

7-10+ years of progressive experience in Quality Assurance and/or Quality Control within the biopharmaceutical industry, with emphasis on cell therapies or biologics.

* Regulatory Expertise:
Demonstrated hands-on experience with FDA and EMA regulations, including GMP compliance requirements for Advanced Therapy Medicinal Products (ATMPs).

* Core Competencies:

Strong analytical and critical-thinking skills, exceptional attention to detail, and the ability to interpret complex regulatory requirements into efficient, practical procedures.

* Adaptability & Growth

Experience:

Proven success working in startup or high-growth environments, including building or scaling a QMS from early-stage development through clinical readiness.

Compensation for the QA Consultant includes:

* Pay Rate: $75-90/hour

* Comprehensive Benefits:
Medical, Dental, Vision, 401k, Sick Leave as required by law

This job opens for applications on 02/13/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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